MXPA06005502A - Apparatus useful for positioning a device on an endoscope - Google Patents

Apparatus useful for positioning a device on an endoscope

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Publication number
MXPA06005502A
MXPA06005502A MXPA/A/2006/005502A MXPA06005502A MXPA06005502A MX PA06005502 A MXPA06005502 A MX PA06005502A MX PA06005502 A MXPA06005502 A MX PA06005502A MX PA06005502 A MXPA06005502 A MX PA06005502A
Authority
MX
Mexico
Prior art keywords
endoscope
component
feeding tube
cap
carrier
Prior art date
Application number
MXPA/A/2006/005502A
Other languages
Spanish (es)
Inventor
David Stefanchik
James T Spivey
Omar J Vakharia
Rick D Applegate
Original Assignee
Johnson&Ampjohnson*
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Johnson&Ampjohnson* filed Critical Johnson&Ampjohnson*
Publication of MXPA06005502A publication Critical patent/MXPA06005502A/en

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Abstract

A medical apparatus and method useful for positioning a device, such as an endcap, on an end of an endoscope, is disclosed. The apparatus can exert a pulling force on the endoscope through the endcap while a pushing force is applied to the endcap. The apparatus can be used to press an endcap onto the distal end of an endoscope without grasping by hand a sheath in those applications where the endoscope is disposed in a sheath.

Description

USEFUL APPARATUS FOR PLACING A DEVICE IN AN ENDOSCOPE CROSS REFERENCE TO RELATED REQUESTS This application claims the priority of the following patent applications, which are incorporated herein by reference: Serial Numbers of E.U.A. 10 / 440,957 (published as US 2004/0230095); 10 / 440,660 (published as US 2004/0230096) and US 10 / 440,956 (published as US 2004/0230097); each filed on May 16, 2003. This application claims the priority of, and incorporates as reference the Patent Application of E.U.A. "Medical Instrument that Has a Guide Wire and an Aggregate Catheter", (Proxy File END-5335USNP5), filed on May 12, 2005 on behalf of Long et al., Which has the Serial Number FIELD OF THE INVENTION The present invention relates generally to medical devices, and more particularly to devices and methods useful in endoscopic procedures.
BACKGROUND OF THE INVENTION Minimally invasive procedures are desirable because such procedures can reduce pain and improve relatively fast recovery times compared to conventional open medical procedures. Many minimally invasive procedures are performed with an endoscope (including, but not limited to, laparoscopes). Such procedures allow a physician to position, manipulate and observe medical instruments and accessories within the patient through a small access opening in the patient's body. Laparoscopy is a term used to describe such an "endo-surgical" procedure, using an endoscope (often a rigid laparoscope). In this type of procedure, accessory devices are often inserted into a patient through trocars placed through the body wall. Even less invasive treatments include those performed through the insertion of an endoscope through a natural body orifice to a treatment site. Examples of this procedure include, but are not limited to, cystoscopy, hysteroscopy, esophagogastroduodenoscopy, and colonoscopy. Many of these procedures employ the use of a flexible endoscope during the procedure. Flexible endoscopes often have a flexible, steerable articulated section near the distal end, which can be controlled by the user using the controls at the proximal end. Some flexible endoscopes are relatively small (1 mm to 3 mm in diameter), and may not have an integral accessory channel (also called a biopsy channel or work channel). Other flexible endoscopes, including gastroscopes and colonoscopes, have integral working channels that have a diameter of approximately 2.0 to 3.5 mm, for the purpose of introducing and removing medical devices and other accessory devices to perform diagnosis or therapy within the patient. As a result, accessory devices used by a physician, may be limited in size by the diameter of the accessory channel of the instrument to be used. In addition, the doctor can be limited to a single accessory device when using the standard endoscope that has a working channel. Certain specialized endoscopes are available, such as endoscopes with large working channels that have a working channel of 5 mm in diameter, which can be used to pass relatively large fittings, or to provide the ability to suction large blood clots. Other specialized endoscopes include those that have two working channels. One of the disadvantages of such endoscopes with large / multiple diameter working channels may be that such devices can be relatively expensive. In addition, such endoscopes with large / multiple diameter working channels may have an outer diameter that makes the endoscope relatively rigid, or otherwise difficult to intubate. Several references describe methods or systems related to an endoscope, such as for example: Patent of E.U.A. 5,025,778, by Silverstein; Patent of E.U.A. 4,947,827, by Opie; US 2002/107530 published on August 8, 2002 in the name of Sauer; Patent of E.U.A. 6,352,503, from Matsui. A disadvantage of known systems is the potential of the distal end of a device used externally of an endoscope to move, which may cause the accessory to lack precision or the ability to be maintained within a desired field of vision of the ability. of formation of images of the endoscope. WO 00/48506, published August 24, 2000, in the name of Herrmann, describes a deformable endoscope with at least one supplementary device. The unit comprising the endoscope and the supplementary device has a non-round cross section. Such a non-circular endoscope can be disadvantageous from the point of view of cost, complexity or ease of cleaning / sterilization. For example, a standard endoscope with a smooth, substantially circular cross section may be relatively easy to sterilize and clean. WO 00/48506, published on August 24, 2000, in the name of Kortenbach describes methods and devices for delivering a medical instrument on the outside of an endoscope to allow the use of instruments too large to fit through the opening of the endoscope. Kortenbach describes a collar for use with an endoscope, elastic straps, a flexible wrap having a reclosable tie line, flexible polymer extrusions and a soft tangential wrap defining an opening having an irregular cross section (collapsible) ). Kortenbach also describes a sliding guide with an inverted T configuration. Endoscopes can also be used with feeding tubes. For example, it is known to advance a feeding tube through an internal channel of an endoscope. It is also known to advance a feeding tube together with an endoscope, holding the distal end of the feeding tube with a pair of forceps extending from a distal end of the endoscope, and "dragging" the feeding tube along the outside of the endoscope while advancing the endoscope to a desired location. Scientists and engineers are still looking for improved devices and methods to introduce medical devices into the gastrointestinal tract, including improved devices and methods for placing feeding tubes in patients.
BRIEF DESCRIPTION OF THE INVENTION The present invention provides methods and devices useful with various medical procedures, including non-exclusively, methods and devices useful with endoscopes, methods and devices employed through natural body orifices, and methods and devices related to the placement of feeding tubes. For example, in one embodiment, the present invention can be used to quickly and consistently place an accessory, such as a feeding tube, in a desired location, such as in the stomach or jejunum, and so that the device remains in the desired position during removal of the endoscope. In certain embodiments, the present invention can be employed to reduce the number of intubations required for certain procedures, such as the number of intubations required to place a feeding tube. In certain embodiments, the present invention may also be employed to reduce the number of steps required in certain medical procedures, such as reducing the steps of oral to nasal transfer in the installation of a feeding tube, reducing the number of times the tools or devices are changed or deployed in the body, reduce the number of hands required to perform a procedure, and / or reduce the number of times the medical professional must change the position of the hand during a procedure. In one embodiment, the present invention provides an apparatus for positioning a device, such as a cap, on one end of an endoscope. The apparatus may include a first component for applying a force to the shell; and a second component operatively associated with the first component and mobile with respect to the first component. The second component can apply a force to the endoscope through an opening in the device. In one embodiment, the first component applies a pushing force on a distal face of the cap, simultaneously with a second component that applies a pulling or pulling force to the endoscope. In one embodiment, the apparatus includes a component that can be selectively expandable within a working channel of the endoscope to provide a drag force on the endoscope. In another embodiment, the apparatus includes a loading member (which can be disposable and formed of a lightweight polymeric material) having a first end sized to pass through the cap, and a second end adapted to releasably engage the Distal end of the endoscope. The loading element may have a plurality of elastic pins for releasably coupling the distal end of the endoscope. In certain embodiments, the invention may be employed with respect to procedures involving tubes for Percutaneous Endoscopic Gastrostomy (PEG) and / or a Jejunal Enteral Tube through Percutaneous Endoscopic Gastrostomy Procedures (JET PEG).
BRIEF DESCRIPTION OF THE FIGURES Figure 1 is a schematic illustration of a sheath and an endoscopic guidewire.
Figure 1A is a schematic illustration of an endoscope inserted in a grip having an articulated clip in an open configuration. Figure 1 B is a schematic illustration similar to that of Figure 1A, showing the articulated fastener in a closed position and the feeding tube and the carrier being advanced in a sliding guide. Figure 2 is a schematic illustration of the distal end of the casing of Figure 1, showing a carrier that is advanced in the slide. Figure 2A is a schematic isometric illustration showing the proximal end of the cap. Figure 3 illustrates different sections of a sliding guide placed in a wrapper. Figure 4 is an illustration of a top view of a portion of a slide. Figure 5 is a cross-sectional illustration of a sliding guide supported on a shell (it is understood that the shell may be formed of a thin film that will not maintain the circular configuration shown in Figure 5 in the absence of an inner member, such as an endoscope, being placed inside the envelope). Figure 6 is a schematic illustration of a carrier of the feeding tube according to an embodiment of the present invention.
Figure 7 is a schematic illustration of a distal portion of a sheath and a slide guide showing a carrier being advanced to a distal position in the slideway, and with an indicator tab extending through a slot in a cap to be observed by an endoscope. Figure 8 is a schematic illustration showing the distal end of an endoscope being advanced through a wrap, with the wrap, the slide and the carrier shown in cross section. Figure 9 is a schematic illustration of a distal portion of a sheath, slide and carrier, and illustrating the carrier and feed tube being advanced to a distal position in the slide. Figure 10 is a schematic illustration of a feeding tube having a feature for providing sliding engagement with a sliding guide. Figure 11 is a schematic illustration of the proximal portion of the feature shown in Figure 10. Figure 12 is a schematic illustration of an opening for use to hold the feeding tube in a desired position in the gastrointestinal tract after the feeding tube is placed and the sliding guide has been removed from the Gl tract.
Figure 13 is an illustration of a schematic side view of a distal portion of the feeding tube shown in Figure 10, illustrating a distal portion of a passage (dotted line), through which nutrients can be directed, in a manner that the distal portion of the passage does not have to flex or bend to communicate with a distal feeding opening, with the portion of the feeding tube extending distally from the distal feeding opening that is inclined with respect to the passage, and the figure illustrates weights (in dashed lines), which can be used at a distal end of the feeding tube. Figure 14 is a schematic illustration of a distal portion of a limb that can be used to hold the feeding tube in a desired position during removal of the endoscope and the Gl tract carrier from the patient. Figure 15 is a schematic illustration of the distal end of the member of Figure 14 and showing the contact surfaces positioned, sized and / or formed for contact by coupling the surfaces at the proximal end of a rail feature associated with a feeding tube. Figure 16 is a schematic illustration of the distal portion of the member of Figure 14 positioned with respect to the proximal end of the rail feature in the feed tube.
Figure 17 is an illustration of a schematic bottom view of adjacent portions of the rail feature in the feed tube and the member of Figure 14. Figure 18 illustrates the introduction of an endoscope into a medical device (medical device which may include a handle, sheath, cap and slide) in the Gl tract of a patient, so that the cap and the distal end of the slide guide are placed in the small intestine (such as in the jejunum). Figure 19 illustrates the advancement of a carrier and a feeding tube together, in the slide guide after the endoscope and the slide guide have been placed as shown in FIG.
Figure 18, so that the distal end of the feeding tube is placed in the jejunum. Figure 20 illustrates feeding a member distally to a position behind the feeding tube, to hold the feeding tube in place in the Gl tract, while the endoscope and the medical device (medical device which may include a handle) , sheath, cap and sliding guide) are removed in a proximal direction of the patient. Figure 21 illustrates the feeding tube positioned to extend from the outside of the mouth to the small intestine. Figure 22 illustrates the proportion of a transfer tube through the nose.
Figure 23 illustrates the association of one end of the transfer tube with the proximal end of the feeding tube. Figure 24 illustrates the proximal end of the feeding tube pulled through the throat and the nasal cavity (such as with the transfer tube of Figure 23), so that the proximal end of the feeding tube extends from the patient's nose (from a nostril) Figure 25 illustrates the placement of an endoscope inside a medical device (medical device which may include a handle, sheath, cap and slide) in the Gl tract, so that the cap and the distal end of the guide Slides are placed in the stomach, such as to be used in a tube feeding method for PEG, and Figure 25 illustrates a cannula / needle to provide a percutaneous incision through the abdominal wall, which can be transilluminated with a source of light associated with the endoscope. Figure 26 illustrates the withdrawal of the needle from the cannula and the Introduction of a loop guidewire through the cannula, and illustrates the distal end of the endoscope, shell, sheath and slide guide passing through the loop of the loop guidewire. Figure 27 advances a PEG tube (such as a PEG tube having a length substantially less than the length of the slide rail) in the slide, with the PEG tube placed on the slide, so that a The first end of the PEG tube to be placed inside the body is advanced forward of a second end of the PEG to be placed through the percutaneous incision, and that shows the first end of the PEG tube that is advanced outside of the guide. glide. Figure 28 illustrates the second end of the PEG tube that is advanced outside the rail and that holds a suture section extending from the second end of the PEG tube with the loop guide wire. Figure 29 illustrates the traction of the suture loop and the second end of the PEG tube through the percutaneous incision and the seating of a stop member at the first end of the PEG tube against the inner surface of the gastric wall, with the endoscope placed to provide observation of the settlement. Figure 30 illustrates the medical device and the endoscope, removed from the Gl tract and the outer portion of the PEG tube adapted to introduce nutrients through the abdominal wall. Figure 31 illustrates the placement of an endoscope (such as a gastroscope), placed in a medical device (medical device which may include a handle, wrap, cap and slide) in the Gl tract, so that the cap, the distal end of the gastroscope and the distal end of the slide guide placed in the stomach, such as for use in a JET-PEG tube feeding method, with Figure 31 also showing that the endoscope can be used to transilluminate the abdominal wall, so that a needle / cannula can be used to make and / or pass through a small incision in the stomach. Figure 32 illustrates the withdrawal of the needle and the introduction of a loop guidewire through the cannula, after which the medical device (with the gastroscope placed therein) can be advanced through the wire. loop guide, with the distal end of the medical device and the distal end of the gastroscope being advanced toward the jejunum (such as beyond the ligament of Treitz). Figure 33 illustrates the placement of a feeding tube (such as a feeding tube having a length substantially less than the length of the sliding guide) and the carrier in the sliding guide, and advancing the feeding tube to along the sliding guide, until the distal end of the feeding tube is placed in the jejunum and can be seen by the endoscope. Figure 34 illustrates the retraction of the medical device and the gastroscope proximally to the stomach, while holding a member positioned proximally behind the feeding tube to push the feeding tube out of the distal end of the sliding guide, and which illustrates the securing a suture section extending from the feeding tube with the loop guide wire. Figure 35 illustrates the pull of the suture and one end of the feeding tube through the incision through the abdominal wall, and leaving a distal end of the feeding tube in the jejunum.
Figure 36 illustrates the external portion of the feeding tube adapted to introduce nutrients through the abdominal wall, with the distal end of the feeding tube being placed in the jejunum. Figure 37 illustrates the feeding tube in place with the gastroscope and medical device removed. Figure 38 illustrates a head loading element that can be used in a cap on the distal end of an endoscope. Figure 38A is a schematic cross-sectional illustration of a flexible spike of the bucket loading element. Figure 39 illustrates the loading element of the cap placed on the distal end of the endoscope, and the endoscope placed on the casing, with the flexible pins of the cassette loading element placed inside the casing and coupling an external surface of the endoscope , with an O-ring that compresses the flexible pins and placed against the proximal face of the cap, and with a distal portion of the cap element that extends through the perforation of the cap. Figure 40 illustrates a handle that slides proximally over the headset loading member to be positioned against the distal face of the headset. Figure 40A is a schematic illustration showing the proximal face of a handle and showing a loading element of the cap extending towards a central bore in the handle.
Figure 41 illustrates a ring that can be attached to a distal portion of the cap element loading member. Figure 42 illustrates the traction distally of the annulus while being pushed proximally on the grip, to provide a pushing force on the distal face of the cap with the grip, while a pull force is provided on the external surface of the cap. endoscope with the flexible pins, so that the cap and the O-ring slide out of the loading element of the cap and towards the distal end of the endoscope. Figure 43 illustrates a schematic isometric view of an apparatus that couples an inner surface of an endoscope and that can be used to push a shell toward an endoscope. Figure 44 is a schematic cross-sectional illustration of the apparatus of Figure 43. Figure 45 is a schematic isometric illustration showing the distal end of an endoscope, the cap, and the front portion of the apparatus of Figure 43, with a portion of the device that is inserted into a working channel of the endoscope. Figure 46 is a schematic isometric illustration showing the expansion of a portion of the apparatus inserted into the working channel of the endoscope. Figure 47 is a schematic isometric illustration showing a backward movement of an actuator of the apparatus of Figure 43, for pushing the cap toward the endoscope in a first direction, while pulling the endoscope in the opposite direction. Figure 48 is a schematic cross-sectional illustration of a portion of the apparatus of Figure 43. Figure 49 is a schematic cross-sectional illustration of a portion of the apparatus of Figure 43.
DETAILED DESCRIPTION OF THE INVENTION Figures 1 and 2 illustrate a medical apparatus 10 according to an embodiment of the present invention. In one embodiment, the apparatus 10 may include a handle 100, a catheter or flexible sheath 200 extending from the handle 100, a flexible glide guide 300 placed in the wrapper 200, and a cap 400 positioned at the distal end of the sleeve. wrapper 200. Handle 100 and flexible wrapper 200 may each be sized to receive an endoscope through. The apparatus 10 may also include a carrier 500 that is adapted to slidely engage the slide 300, as shown in Figure 2. The shell 400 can be sized and formed to couple the distal end of an endoscope, such as an endoscope 1000 as shown in Figure 2. The endoscope 1000 may be any commercially available endoscope, such as a gastroscope or colonoscope having an articulated distal section, and including an observation element 1100 and a working channel. 1200. Any suitable endoscope, including non-exclusively, gastroscopes and pediatric colonoscopes, can be used with the present invention. Endoscopes suitable for use with the present invention include, but are not limited to, endoscopes, model PCF100, PCF130L, PCF140L, or PCF160AL, manufactured by Olympus Corporation of Japan. The handle 100, the wrapper 200 and the cap 400 can be sized to receive endoscopes of various diameters, such as, but not exclusively, endoscopes having a diameter of about 9 mm to about 14 mm. To insert the endoscope 1000 with the apparatus 10 into a patient, the operator can start with a dry, clean endoscope. The wrapper 200 is preferably formed of a thin, lightweight, falling polymeric material, which can be relatively soft and elastically extensible, and which has substantially no torsional stiffness and is not capable of carrying a torsional load. By "drop", it is understood that the wrap does not maintain a circular cross-sectional shape or other regular shape in the absence of an internal structure (such as an endoscope), which supports the wrapper. In one embodiment, the envelope 200 may be formed of a material having an elastic modulus less than about 20 ksi, more particularly, less than about 15 ksi, still more particularly, less than about 10 ksi, and even more particularly, less than about 7 ksi. The wrapper can be formed of a material having an elastic limit less than about 35.15 kgf / cm2 (500 psi), more particularly less than about 21.09 kgf / cm2 (300 psi), even more particularly less than about 14.06 kgf / cm2 (200 psi), and even more particularly less than about 8.78 kgf / cm2 (125 psi). In one embodiment, the wrapper can be formed of a material having an elastic limit of between about 6.32 kgf / cm2 (90 psi) and about 8.43 kgf / cm2 (120 psi). The elastic modulus and elastic limit can be determined as an average of five or more measurements, and can be determined using the ASTM # D882 test (Standard Test Methods for the Traction Properties of a Thin Plastic Sheet), using a length of the calibrator of 10.16 centimeters (4.0 inches), a gauge width of 2.54 centimeters (1.0 inches), a test thickness equal to the thickness of the film (for example, approximately 0.127 millimeters (0.005 inches)), and a machine speed of 1,016 centimeters / minute test (0.4 inches / minute). In one embodiment, the wrapper can be formed of a film having a modulus less than about 7 ksi, an elastic limit less than about 8.78 kgf / cm2 (125 psi), and a tensile strength at breaking (measured in accordance with ASTM D 638) of at least about 1 MPa (megaPascal), more particularly at least about 5 MPa, and even more particularly about 10 MPa or greater. The wrap can be formed of a film having a tensile elongation (measured using ASTM D 638), of at least about 200 percent, more particularly at least about 500 percent, and even more particularly about 800 percent or more. The modulus, the elastic limit, the tensile strength and the elongation are determined as the average of at least five measurements. In some embodiments, it may be desirable that the wrapper 200 be inserted over the insertion length of the instrument to be viewed without the use of a lubricant. In one embodiment, the wrapper 200 may have a textured inner surface, not smooth 210, which prevents the inner surface of the flexible envelope from "adhering" to the outer surface of the insertion portion of the endoscope. The textured inner surface can also help to hold the endoscope through the wrapper 200, such as, for example, if it is desired to rotate the wrapper and the endoscope together. The inner surface can be textured and the outer surface can be generally smooth, or both the inner and outer surfaces can be textured. The inner surface of the wrapper 200 may have the same texture as the outer surface, be relatively more textured than the outer surface, or be relatively less textured than the outer surface. The textured inner surface may be provided with raised portions, recessed portions or combinations of raised and recessed portions. For example, the inner surface may include separate protrusions or protrusions randomly or alternately, it may be provided by raised portions (such as ridges, protrusions or protuberances) appearing at regularly spaced intervals, intervals which may be of a generally uniform separation. The texture of the inner surface can be measured in terms of an average roughness measurement, where the "average roughness" or "Ra" is the arithmetic average of the absolute values of the measured deviations of the height of the profile divided by a evaluation length, as set out on page 728 of the 27th edition of the Machinery Manual, 2004, incorporated herein by reference. The average roughness can be measured using optical interferometry with a Zygo NewView 100 3D Surface Image Analyzer marketed by Zygo Corporation of Middlefield, Conn. The following measurement parameters and analysis parameters can be used: Measurement Parameters: The Acquisition Mode is "Explore"; Camera Mode is 320x240 Normal; Phase Controls (AGC is "ON", Phase Resolution is "High", Minimum Mode is 1%, Minimum Area Size is 7, Discon Action is "Filter", Connection Order is "Location "; Strip Elimination is" Off "; Approach of Image is 1x); Scan Controls (Scan Length is "Extended", Extended Scan Length is 0.2794 millimeters (11000 microinches), FDA Resolution is "Low").
Analysis Parameters: The Filter is "Low Pass"; the Filter Type is "Average"; The Size of the Filter Window is 13; High Frequency Filter 1 / thousandth of an inch; Low Frequency Filter 1 / thousandth of an inch; Filter Compensation is "Off"; the Elimination is "Flat"; Compensation is 0; Tip Elimination is "ON"; the Height of the Point (xRMS) is 1.25; the Data Ratio is "ON"; The Maximum Data Ratio is 25. The measurements can be made with a Michelson 5x Objective Lens, and the samples can be coated with gold or otherwise coated to provide a generally opaque surface that reflects light. The coating with gold can be applied with a Hummer 6.2 Cathodic Spray System. In one embodiment, the inner surface of the wrapper 200 may have an average roughness value Ra less than about 0.0127 millimeters (500 microinches (0.000500 inches)), more particularly less than about 0.01016 millimeters (400 microinches), even more particularly less than about 0.00635 millimeters (250 micropulgadas), and even more particularly less than about 0.00381 millimeters (150 micropulgadas). In one embodiment, the average roughness value of the inner surface may be between about 0.00127 (50) and about 0.0127 millimeters (500 microinches), more particularly between about 0.00127 (50) and about 0.00635 millimeters (250 microinches), and yet more particularly between about 0.001905 (75) and about 0.003175 millimeters (125 microinches). The average roughness value is determined as the average of at least five measurements. The inner surface of the envelope 200 may have a coefficient of friction that is suitable for holding the endoscope with the envelope 200, but also allowing the endoscope to be placed inside the envelope without undue stress. A suitable internal surface may have a coefficient of static friction and a coefficient of sliding friction which may both be less than about 1.0. In one embodiment, the coefficient of static friction can be between about 0.3 and about 0.6 (more particularly between about 0.4 and 0.5) and the sliding friction coefficient can be between about 0.3 and about 0.6 (more particularly between about 0.4 and about 0.5). ), using a friction slide formed of an Ultem 1000 material. The coefficient of static friction can be between about 0.2 and about 0.5 (more particularly between about 0.3 and about 0.4), and the coefficient of friction by sliding can be between about 0.2. and about 0.5 (more particularly between about 0.3 and about 0.4), using a friction test slide formed of 440C stainless steel. The coefficient of static and sliding friction can be measured using the ASTM test # D1894 (Standard Test Method for Static Friction Coefficients and Kinetics of a Film and Plastic Sheets). The coefficient of friction is determined as the average of at least five measurements. In one embodiment, the wrapper 200 may be formed of a thermoplastic polyolefin film having a thickness of less than about 0.254 millimeters (0.010 inches), and may comprise polypropylene, polyethylene, and mixtures thereof. In one embodiment, the wrapper can be formed of a film having a thickness of between about 0.1016 to 0.1524 millimeters (0.004 to 0.006 inches), more particularly about 0.127 millimeters (0.005 inches). A suitable film is available as Basell Softell Q020F, made by Basell NV, Hoofdorp, The Netherlands, which may be provided by Specialty Extrusion, Inc. of Royersford, Pa. Handle 100 may be formed of any suitable material, including non-exclusively, relatively rigid biocompatible metals and plastics. A suitable material from which the handle 100 can be formed is molded polypropylene, such as that available as Huntsman 12N25ACS296 from Huntsman Corp. of Houston TX. As shown in Figure 1, the handle 100 can have a generally cylindrical proximal section 102, having a proximal opening for receiving an endoscope, and an adjacent conical section converging distally 104. The handle 100 includes an opening 101 at its end proximal to receive an endoscope. The internal channel of the handle for receiving the endoscope may include a generally cylindrical channel section 103 (shown in dashed lines), corresponding to section 102, and a generally tapered channel section 105 (shown in dashed lines), which corresponds to section 104. The section of the generally conical channel 105 may taper from a relatively large internal diameter to a relatively small internal diameter, as the channel section 105 extends distally. A support structure of the slide guide 120, as shown, extends from the sections 102 and 104 to support a slide of the slide guide 130 at an angle inclined with respect to the longitudinal axis of the sections 102 and 104. slide ramp 130 can support the proximal portion of the slide 300. Figures 1A and 1B illustrate isometric views of an endoscope 1000 inserted in a grip 100. An articulated clip 140 can be placed on or adjacent to the proximal end of the slide guide 300. The clip 140 may be articulated to the ramp of the slide 130 or the structure 120, such as by an active hinge or a mechanical pin type hinge. The fastener is shown in an open position in Figure 1A and a closed position in Figure 1B. The fastener, when in the closed position, extends over the slide guide 300 at, or adjacent to, the proximal end of the slide and may help to prevent the components slidably supported on the slide guide 300 from being slid. "come out" of the sliding guide 300 or are otherwise dislodged from the sliding guide 300 during use. In Figure 1 B, a carrier 500 and a feeding tube 600 (both described in more detail below), are shown being advanced by hand in a distal direction along the slide 300. An elastically extensible member can used to provide a distal deflection force in the endoscope and a proximal deflection force in the grip 100. For example, the grip 100 may include an elastic strap 150 (shown in Figure 18 and 19). The elastic strap can extend from a portion of the handle 100, such as the slide guide ramp 130 or the structure 120, to form a loop enclosing a portion of the endoscope 1000, such as an opening of the accessory channel of the endoscope. The elastic strap 150 is useful for accommodating a variation in the lengths of the endoscope, helping to maintain the tension of the wrap, and helping to maintain the coupling of the endoscope in the grip. The elastic strap can be used to compensate for changes in length due to the bending of the instrument to watch, and to provide an elastic biasing force that drives the endoscope distally towards the handle and the sheath. Alternatively, instead of an elastic strap, a relatively inelastic strap could be used, and a biasing member could be used on the handle or wrap to hold the sheath and the slide without folding or "bunching" together. another way in the endoscope.
For example, the strap may be generally nextensible, and the handle may be formed of an elastically extensible material or geometry, so that the length of the handle would extend when the strap engages a relatively large endoscope. The shell 400 can be formed of a thermoplastic elastomer to fit the distal end of the endoscope 1000. The shell 400 can be formed of a material having a durometer of less than about 100, and more particularly between about 50 and about 90 (measured using an A scale, 3,048 millimeter (0.120 inch) test in accordance with ASTM D2240). The cap can be pressed on (eg, slightly expanded to fit) the distal end of the endoscope with the distal end of the endoscope being held by the cap 400. A suitable material from which the cap 400 can be formed, is a molded thermoplastic elastomer, marking Santoprene. It may be desirable to provide a cap 400 of a material such as a thermoplastic elastomer, since such a cap 400 can be pressed onto the distal end of the endoscope, as described in more detail below. Referring to Figures 1, 2 and 2A, the cap 400 may include a generally cylindrical body portion 410, a distal face 412, a proximal face 414, and an aperture of the central perforation 420 through, to receive the distal end of the cap. endoscope 1000. The cap 400 may have internal, circumferentially extending slits 422, spaced along the length of the inner surface of the aperture of the central perforation 420. A recess of the slide 424 may be provided (Figure 2A ) in the upper half of the body portion 410. The recess 424 may extend distally from the proximal face 414, and may be sized and formed to receive the distal end of the slide 300. If desired, the proximal end perforation opening 420 can be tapering or beveled to help press the cap on the distal end of the endoscope. The shell 400 may also include a slot 430 (Figure 2 and 2A), which extends through at least a portion of the body portion 410 and an opening in the distal face 412. The slot 430 may extend distally from a surface bordering the hollow of the slideway 424, to be positioned with respect to the slideway 300, so that it is generally in the same "in point" position as the slideway 300. The slot 430 can be sized and formed to receive a tab or other indicating device, as described below. In one embodiment, the proximal end of the slot 430 may be generally aligned with the channel 320 in the slide 300 (described below), and the distal end of the slot 430 may tilt radially inward as the slot 430 extends from the recess 424 in the distal direction, so that a tab or other indicating device that extends through the slot 430 is directed distally and radially inwardly to be observed by the optical instruments of the endoscope 1000. The cap 400 can attaching to the distal end of the envelope 200 by any suitable method, such as ultrasonic welding. The sliding guide 300 can be supported by the casing 200, and can extend from the handle 100 towards the cap 400. Figure 3 shows the sliding guide 300 supported on the casing 200 with a portion of the sliding guide shown in dashed lines . Figure 4 illustrates a flat top view of the slide 300, and Figure 5 illustrates a cross-sectional view of the slide guide 300 supported by the wrapper 200. In Figure 5, the wrapper 200 is shown in section transverse as it would appear if placed in an endoscope for purposes of illustration, it being understood that, in one embodiment, the wall of the envelope 200 may be generally flaccid and falling, and lacks sufficient rigidity to maintain the shape shown in Figure 5 without the support of the endoscope or other internal support. The sliding guide 300 can generally be a piece of continuous, unitary material, extending longitudinally a sufficient length to reach a point outside the patient at a point at, or distal to, the patient's stomach, such as through the pylorus and small intestine. The slideway 300 can be formed of a flexible polymeric material, such as extruded polypropylene. A suitable material from which the slideway 300 can be formed is Huntsman 23R2Acs321, available from Huntsman Corp. of Houston TX. The wrapper 200 can be attached to the slideway 300 by any suitable joining method, such as ultrasonic welding. The distal end of the slide 300 can be overmoulded in the cap 400, or otherwise attached to the cap 400 in the recess 424. The handle 100 can be attached to the proximal end of the sheath 200 and the proximal end of the slide guide 300 by any suitable method, such as ultrasonic welding. The sliding guide 300 may include a channel body generally in the shape of C 310, which defines an inverted T-shaped channel 320 in cross section. The body 310 may include a floor 312, vertical side walls 314, and inwardly extending pins 316. The body 310 may also include a plurality of circumferentially extending side tabs 330, which extend outwardly from the body 310. adjacent tabs 330 on each side of the slide 300, may be separated, such as by scalloping (shown in Figure 3 in broken lines), or by other separation methods, such as staggering, to maintain the flexibility of the guide 300. The tabs 330 are shown attached to the inner surface 210 of the wrapper 200. The tabs 330 may be attached to the inner surface 210 by any suitable means, such as with adhesive or other joining methods. Without being limited by theory, the tabs 330 can be used to stabilize the slide guide 300 with respect to the endoscope, when the endoscope is placed in the wrapper 200. The tabs help maintain the radial alignment of the axis of symmetry of the channel of the slide guide 320 with respect to endoscope 1000. accordingly, wrapper 200 and slide guide 300 can be rotated circumferentially as a unit, around endoscope 1000 at different spot positions, and tabs 330 help maintain the slide guide 300 (and channel 320) in the proper radial orientation with respect to the endoscope. The desired radial orientation of the channel 320 is illustrated in Figure 5, with the center line and the axis of symmetry of the cross section of the channel 320, being generally aligned with a radial line extending from the center of the endoscope. According to one embodiment of the present invention, the slide 300 has at least one portion that has greater flexibility than another portion of the slide. For example, the sliding guide 300 may include a portion having a flexibility of curvature and an axial flexibility that is greater than the flexibility of curvature and the axial flexibility of another portion of the slide. Referring to Figure 3, the slide guide 300 is shown schematically as having three sections of different flexibility. Section A, which may be the most distal portion of the glide guide 300, may be the more flexible portion of the glide guide in both the curvature and axial extent. Section A may be associated with the most distal portion of the endoscope, such as the articulation portion of the endoscope. Section B may be relatively less flexible (stiffer) than Section A. Section C may be the proximal portion of the slide 300 and may be relatively less flexible than region B. In one embodiment, Section A may be extend approximately 25.4 centimeters (10 inches), and Section B can extend approximately 66.04 centimeters (26 inches). In one embodiment, the length of the slide 300 can be at least about 127 centimeters (50 inches). In the embodiment shown in Figures 3 and 4, Sections A and B are interrupted at intervals along their respective lengths, to reduce the bending stiffness and axial stiffness of the regions, while Section C may be generally not interrupted. The interruptions in Sections A and B are provided by a series of slits 340. As shown in Figures 3 and 4, the slits 340 in the two sides of the slide guide body 310 are alternated (longitudinally offset) with relative to the others, so that the slits in one side of the body of the sliding guide 310 are not aligned with the slits in the other side of the body of the sliding guide 310. In the embodiment shown, each slit 340 in a The side of the sliding guide is placed halfway between the two adjacent slits on the opposite side of the sliding guide. Each of the tabs 330 can be placed between a pair of adjacent slits 340. In one embodiment, the slits 340 can have a width (measured in parallel to the length of the channel 320) of less than about 0.254 millimeters (0.010 inches), more particularly, less than about 0.127 millimeters (0.005 inches). The slits 340 may be formed by any suitable blade or other cutting instrument. Without being limited by theory, the width and alternation of the slits 340 can provide sufficient flexibility of the slide guide 300, while preventing a member slidably placed on the slide from "slipping" off the carrier, or jump "from the sliding guide, such as by deflection of the pins 316, in positions where the endoscope is flexed (or other configuration where the sliding guide is flexed and otherwise takes a curved configuration). The provision of interruptions selectively positioned in the slide guide allows the slide guide to follow the curvature of the endoscope without significantly increasing the curvature rigidity of the envelope assembly 200 and the endoscope. In one embodiment, the slits 340 extend through the full thickness of the slide (the thickness is measured in the vertical direction in Figure 5). Additionally, the slits may extend from one side of the slide to extend across the full width of one of the pins 316, and the slits may extend at least half through the floor 312. In the embodiment shown in FIGS. Figures 3 and 4, each of the slits 340 can extend through the entire thickness of the sliding guide. In addition, depending on the location of the slits 340 along the slide, the slits 340 may extend more than half, but not completely across the width of the slide. For example, the slits 340 extends through the longitudinal center line of the sliding guide in Section A of Figure 3. Referring to Figure 5, the dimension W illustrates the width of a slit that extends more than the width of the slit. half, but not completely through the width of the sliding guide. The gap 342 (Figure 3) between the slits 340 on the same side of the slide 3090 can be from about 0.3048 (0.120) to about 0.3302 centimeters (0.130 inches) in Section A and about 0.635 centimeters (0.250 inches) in Section B. The alternating arrangement of the slits 340 extending beyond the center line of the sliding guide, may provide the advantage that the sliding guide 300 does not have a longitudinally continuous load path for transporting the tensile loads or the loads of curvature. Without being limited by theory, the alternating arrangement of the slits 340 may be observed as providing bending sections (indicated by reference number 344 in Figure 4), in the slide guide 300. The flexure sections 344 may having a length 346 (Figure 4), defined by the number of slits 340 on opposite sides of the overlap of the slide, and the bending sections 344 have a width 348 defined by the longitudinal separation of a slot slit. immediately adjacent that extends from the opposite side of the sliding guide. In one embodiment, length 346 may be from about 0.9652 millimeters (0.038 inches) to about 1.016 millimeters (0.040 inches) in Section A, and width 348 may be about 1.5875 millimeters (0.0625 inches). Figure 6 illustrates a carrier 500, and Figure 7 illustrates the carrier 500 being advanced to a more distal position on the slide 300. The carrier 500 can extend from a proximal end 502 to a distal end 504. The length of the carrier 500 may be a sufficient length to reach from a point outside the patient to a point within, or distal to, the patient's stomach. In one embodiment, the length of the carrier 500 may be at least about 100 cm, and more particularly, at least about 182.88 centimeters (72 inches). The carrier 500 may include a body 520, a generally extending vertical mesh 530, and a sliding guide coupling rail 534. The carrier 500 slidably engages the sliding guide 300, with the rail 534 being dimensioned and formed to be slidable within the channel 320 of the slide 300. The carrier 500 may be of unitary construction, and may be molded or otherwise formed of a suitable material. In one embodiment, the carrier 500 is formed of relatively low friction materials, such as extruded PTFE (Teflon).
Figure 8 provides a cross-sectional illustration of the carrier 500 supported on the slide 300, with the distal end of the endoscope 1000 illustrated as being advanced through the cross section to illustrate a position of the components at the distal end of the endoscope relative to the position of the slide 300. As shown in Figure 8, the mesh 530 extends generally radially inward from the body 520, to place the rail 534 radially inward of the carrier body 520. The cross section of the mesh 530 and the rail 534, together, can provide a generally inverted "T" configuration. The body of the carrier 520 may include a channel 522. The channel 522 may extend substantially over the entire length of the body 520. The channel 522 may be limited by a floor of the channel 512 and opposite side walls 514. The body 520 also it may include inwardly extending pins 516, which have opposite oriented sides 518, which are spaced apart to define the throat of the channel opening 522. The more distal portion of the rail that engages the slideway 534 may extend distally beyond the body 520 to provide a flexible indicator tab 536. The tab 536 may be sized and formed to be received by the slot 430 in the cap 400. As the carrier 500 is advanced distally in the slide 300, the tab 536 it will be observed by the optical instruments of the endoscope 1000 once the carrier 500 has reached its most distal position in the guide of Sliding 300. Referring to Figures 7 and 8, the tab 536 can be seen through the optical element of the endoscope 1100 as the tab 536 is advanced distally and radially inwardly from the distal end of the slot 430. In one embodiment, the carrier 500 has at least one portion that has greater flexibility than another portion of the carrier. For example, the carrier 500 may include a body 520 having a distal portion 520A, which has a flexibility of curvature and an axial flexibility that is greater than a portion of the more proximal body 520B of the carrier. Referring to Figure 6, the carrier is shown schematically as having two sections of different flexibility. The section of the carrier 520A may be the most distal portion of the carrier, and may be the most flexible portion of the carrier in both the curvature and axial extent. Section 520A may have a length of at least about 5.08 centimeters (2 inches). In one embodiment, the length of Section 520A is between approximately 10.16 centimeters (4 inches) and approximately 25.4 centimeters (10 inches), and more particularly, the length of section 520A may be between approximately 15.24 (6) and approximately 20.32 centimeters (8 inches). In the embodiment shown in Figures 6 and 7, the body section 520A is shown interrupted at intervals along its length, to reduce the bending stiffness and axial stiffness of the distal portion of the body 520. Interruptions may be provided by a series of slits 540. As shown in Figures 6 and 7, the slits 540 on the two sides of the body of the carrier 520, are alternated (longitudinally offset) with respect to each other, so that the slits in a side of the body 520 are not aligned with the slits on the other side of the body 520. In the embodiment shown, each slit 540 on one side of the body of the carrier is positioned axially in the middle between the two adjacent slits on the opposite side of the guide Sliding. Adjacent pins 516 can be separated by slits 540. Without being limited by theory, flexible tab 536 and slits 540, can help prevent the distal portion of carrier 500 from "jumping" from or "coming out" of the sliding guide. For example, the flexible tab 536 can "unite" the space between the slits 340 in the slide 300, to help prevent the carrier from discharging radially from the slide guide 300. Without being limited by theory, width and alternating slits 540, may also provide sufficient flexibility of the carrier 500, while preventing a member slidably placed in the carrier from "coming off" the carrier, or "jumping" from the carrier. In one embodiment, the slits 540 may extend through the full thickness of the slide (the thickness is measured in the vertical direction in Figure 8). In addition, the slits may extend from one side of the slide to extend across the full width of one of the pins 516, and the slits may continue through at least a portion of the floor 512. Each of the slits 540 may extend through the entire thickness of the body of the slideway 520, and each of the slits 540 may extend more than half, but not completely, across the width of the slideway. The spacing 542 (Figure 6) between the slits 540 on the same side of the body of the wearer may be between about 0.254 centimeters (0.1 inches) and about 1.524 centimeters (0.6 inches) in the body portion of the wearer 520A. The alternating arrangement of the slits 540 provides the advantage that the body portion of the carrier 520A does not have a longitudinally continuous load path to carry tensile loads or bending loads. Figures 9-13 illustrate a feed tube 600, which can be used with the slide guide 300 and the carrier 500. The feed tube 600 can have a proximal end 602 and a distal end 604. The feed tube 600 can including a body of the feeding tube 610 having a passage for the nutrients 620 to pass the nutrients, and a feature 660, adapted to provide the releasable coupling of the feeding tube 600 with another member. For example, feature 660 may include a rail to provide sliding engagement of the feed tube with a slide or carrier 500.
The passage 620 may extend from the proximal end 602 to an exit opening 622 through which the nutrients exit the passage 620 and enter the Gl tract of the patient. The portion of the feed tube 600 that extends distal to the outlet opening 622 may be inclined with respect to the longitudinal axis of the passage 620, as shown in Figures 10 and 13, and with the outlet opening 622 having a elongated configuration, generally tapered. Accordingly, as shown in Figures 10 and 13, the passage 620 may be generally parallel to the longitudinal axis of the feed tube 610, and the passage 620 does not bend or curve to communicate with the exit opening 622, except to the degree that the tube 610 itself is bent. By having the passage 620 which runs substantially straight to the outlet opening 622 and the portion of the distal tip of the feed tube inclined with respect to the passage 620, the advantage can be provided that the passage 620 can be easily cleaned, such as by running a wire from the proximal inlet of the feed tube through the passage 620 and out through the exit opening 622. Referring to Figure 12, the feed tube 600 may include one or more suction openings positioned either proximally or distally of the outlet opening 622. The suction openings can be used to hold the distal end of the tube 600 at a desired position within the body, once the tube 600 is placed, and to prevent migration of the supply tube 600 during feeding. In Figure 10, a suction opening 680 is shown positioned distally of the exit opening 622. The suction opening 680 may include a plurality of tabs extending radially inward 682, which may engage and hold the tissue when the tissue it is withdrawn from the tube 600 by vacuum applied to the suction opening 680. The tabs 682 can be formed by cutting or shaving the outer wall of the tube body 610, to create the tabs 682, or the tabs 682 can be provided in a separate member, such as a metallic or non-metallic insert that is formed to include the tabs 682, and which is placed in an opening in the wall of the tube body 610. Vacuum can be communicated to the suction opening 680 through a vacuum passage ( not shown), which communicates with, or extends separately from, the passage for nutrients 620. Dumbbells 690 may be placed at the distal end of tube 600, to assist in maneuvering and positioning the feed tube 600. The feature 660 can extend along at least a portion of the length of the feed tube 600. In Figure 10, feature 660 is shown as extending along something. , but not the entire length of the feed tube 600. The feature 660 may extend from a proximal end 662 of the feature 660 to a distal end 664. The proximal end 662 of the feature 660 may be separated from the proximal end of the feed tube. 600 by a distance L, so that the portion of the feeding tube 600 that extends through the throat and / or nose of the patient when the feeding tube 600 is in place, does not irritate the patient or interfere with feeding . The distance L can be between approximately 15.24 centimeters (six inches) and approximately 60.96 centimeters (24 inches), and in one embodiment, it is approximately 45.72 centimeters (18 inches). The feature 660 may be formed integrally with the tube body 610 (such as by molding or extrusion). Alternatively, the feature 660 can be fabricated separately from the body of the tube 610, and subsequently joined to the body 610, such as by the use of any suitable bonding or joining method. The feature 660 can be sized and formed to allow the feed tube 600 to be releasably attached to another member, such as the sliding guide 300 or the carrier 500, such as by sliding coupling. In Figure 9, the feed tube 600 is shown slidably supported on the carrier 500. The feature 660 may comprise a rail 666 and a 668 mesh, with the mesh 668 extending generally radially from the tube body. 610, to support the rail 666 in a separate relation to the body of the tube 610. In Figure 9, the rail 666 is placed in a channel 522, with the mesh 668 extending through the throat of the channel 522. Without being limited by theory, it is believed that slidably supporting the feed tube 600 in the carrier 500, while slidably supporting the carrier 500 in the slide guide 300, is advantageous in providing a smooth, friction fit relatively low of the 600 feeding tube inside the patient. Alternatively, the feed tube 600 could be slidably supported directly on the slide 300, such as having the rail 666 directly engage the slide 300. For example, if desired, the slide rail 300 could be coated with Teflon or any other suitable low friction coating. Figure 11 illustrates the proximal end 662 of the feature 660. A tapered surface 672 may be provided at the proximal end 662 to prevent the fabric from being caught or crushed as the mesh 668 and the rail 666 slide with respect to the channel 522 of the carrier 500. The proximal end of the rail 666 may be formed, such as by tapering, to provide contact surfaces 674, positioned at the proximal end of the rail 666, on either side of the mesh 668. The contact surfaces 674 may be angled with with respect to the longitudinal axis of the feeding tube 600 (in Figure 11, the surfaces 674 are inclined to extend outwards as they extend distally). The contact surfaces 672 provide a surface on which a force can be provided to the feature 660, in order to push the feed tube 600 distally along the carrier 500. The orientation of the contact surfaces 672 can be selected with respect to to the longitudinal axis of the feed tube 600, so that the force applied to push the tube 600 distally in the carrier 500, does not tend to push the feature 660 out of the channel 522 in the carrier 500. If desired, the carrier 500 and the 600 feeding tube with characteristic 660, can be packed together. For example, the carrier 500 and the feeding tube 600 can be packaged together, with the feeding tube 600 preassembled in the carrier 500, such as by sliding coupling the tube with the carrier 500. The mounting of the carrier 500 with the tube 600 supported along the length of the carrier, it can be unpacked (such as from a sterile package) at the point of use, and the mounting of the carrier 500 and the tube 600 can be advanced along the slide 300. Figure 14 is an illustration of a side view of the distal portion of a positioning member of the feeding tube 700. The member 700 can be used to push the feeding tube distally along the carrier 500 and / or maintain the feeding tube 600 in a desired position in the Gl tract, as the endoscope is removed from the patient. Figure 15 is an amplified illustration of the distal end of the member 700. Figure 16 illustrates the member 700 positioned to hold the feeding tube 600 in a desired position, and Figure 17 is an enlarged bottom view of the distal end coupling of the member. 700 with the proximal end 662 of the feature 660 in the feed tube 600. In one embodiment, the length of the member 700 can be at least about 91.44 centimeters (36 inches), so that the member 700 can extend from a point outside the patient to engage the contact surface 672 in the feeding tube 600, when the feeding tube is placed in a desired location in the Gl tract of the patient. Referring to Figures 14 and 15, the member 700 may have a structure similar to that of the carrier 500. Alternatively, the member 700 may have a different cross-sectional shape. The member 700 may include a portion of the body 710, which may include slits 740 to provide flexibility. The member 700 may include a rail 766 and a mesh 768, with the mesh 768 extending from the body 710, to support the rail 766 in a separate relationship in the body 710. The rail 766 may be sized and formed for movement by sliding within the channel 520 of the carrier 500. As shown in Figure 15, the distal end 702 of the member 700 may have a tapered surface 772 in the body portion 710. The distal end of the rail 766 may be formed to have a V-shaped notch with two surfaces 774 which are provided for coupling the surfaces 674 in the feed tube 600. The surfaces 774 are positioned distally of the surface 772, and are dimensioned and formed to contact the surfaces 674 in the feeding tube 600, so that the rail 766 of the member 700 can be used to exert a force on the rail 666 of the feeding tube, which force is generally parallel to the rail 766 and to the rail 666. Such surfaces can provide a desired longitudinally directed force without a radial force component or other component of force that can urge the feed tube 600 out of the carrier 500 in an undesired manner. The endoscope with a cover 200 and a sliding guide 300 may be placed in a patient, such that the distal end of the endoscope is placed in a desired position within the Gl tract for placement of the feeding tube. The feeding tube 600 can be placed in the carrier 500, the feeding tube sliding in the carrier 500 outside the patient (or the feeding tube 600 and the carrier 500 can be provided in a pre-package assembly), and the carrier 500 and the tube of feed 600, can then be advanced together, along the slide 300, to a desired position in the Gl tract, such as with the distal portion of the feeding tube placed in the stomach or small intestine. The tab 536 on the carrier 500 can be seen through the optical instruments of the endoscope, since the tab 536 extends through the cap 400, thereby providing a visual indication that the carrier and feeding tube have reached the desired position. Alternatively, the carrier 500 can be advanced along the slide guide 300, and then the feed tube 600 can be advanced along the carrier 500 to the desired position.
Once the distal end of the feeding tube 600 has been advanced to a desired position in the body, the endoscope, the envelope 200, the slide 200, and the carrier 500, can be removed from the Gl tract leaving the tube feeding instead. In order to prevent the feeding tube from "coming back" or moving in another way in a proximal direction, as the other components are removed from the body, the feeding tube fitting member 700 can be used to maintain the position of the tube. of feeding during the withdrawal of the other components. After the placement of the feeding tube 600 (and before removing the endoscope, the wrapper 200, the slideway 300 and the carrier 500), the member 700 can be inserted into the holder 500 (with the rail 766 placed in the channel 520 of the carrier 500, so that the member 700 slidably engages the carrier 500), and the member 700 can be advanced distally along the carrier 500, until the distal end of the member 700 is adjacent the proximal end 662 of the rail 666 in the feeding tube 600. As the endoscope, the wrapper 200, the slide guide 300 and the carrier 500 are withdrawn in a direction proximal to the patient's body, the member 700 can be held in place (such as by the hands of the physician, the physician's assistant or a device), to keep the member 700 stationary with respect to the endoscope, the casing, the slide and the carrier, and exert a force on the tube rail feeding 666 at the interface of surfaces 774 and surfaces 674, thereby "blocking" the feed tube 600 from the proximal return during extraction of the endoscope and other components. Figures 18-24 illustrate the steps that can be employed in a method for positioning a feeding tube, according to an embodiment of the present invention. The endoscope can be inserted into the casing 200, with the cap 400 positioned at a distal end of the casing 200, the handle 100 positioned at a proximal end of the casing 200, and with the slide guide 300 extending along the length of the casing. the shell 200 of the shell 400 towards the handle 100. As used hereinafter, the term "assembly of the shell" will refer to the assembly of the shell 200, the handle 100, the shell 400 and the slide 300. inserting the endoscope into the envelope assembly outside the patient, the envelope assembly and the endoscope can be inserted into a natural bodily opening, such as the mouth, and the assembly of the envelope with the endoscope can be advanced, so that the distal end of the endoscope and the cap 400 are placed in a desired location, such as the small intestine. Figure 18 illustrates the assembly of the sheath placed in the Gl tract of a patient, with the glide guide 300 extending from a position outside the body to a position in the small intestine. The feeding tube 600 can be placed in the carrier 500 outside the patient's body, such as by sliding the feed tube rail 666 into the channel 520 of the carrier 500, until the feeding tube 600 is positioned along the carrier 500 , with the distal end of the feeding tube positioned at or adjacent the distal end of the carrier 500. Referring to Figure 19, the carrier 500 and the feeding tube 600 can then be advanced (such as by the hand in the direction of the arrow 2), together, along the slide guide 300, with the carrier and feeding tube being advanced from a position away from the patient to a position where the distal end of the feeding tube is placed in a desired location (the small intestine in Figure 19). The length of the feeding tube 600 may in one embodiment be at least about 140 cm long, and the distal end of the feeding tube may be positioned between about 130 to about 140 cm from the patient's incisions. By way of non-limiting example, a feeding tube of type 10 Fr Dobb-Hoff of length of 140 cm (available from Viasys Healthcare, Inc.), can be modified to have the characteristic of rail 666, by joining or otherwise adhering a mesh and a rail to the tube. A pediatric colonoscope, such as the Olympus PCF100 pediatric colonoscope with the casing assembly, can be used. Referring to Figure 20, once the feeding tube 600 is in the desired position, the member 700 can be advanced distally (such as by the hand in the direction of the arrow 4) along the slide 300 until the distal end 702 of the member 700 makes contact with the proximal end of the rail 666 of the feed tube 600. Next, as the member 700 is held stationary with respect to the patient's body and the casing assembly, the the envelope (with the endoscope), and the carrier 500 can be removed proximally from the body, in the direction indicated by the arrow 6. Any tendency of the feeding tube 600 to move proximally during the extraction of the endoscope, the assembly of the envelope and the carrier 500, is prevented by butt-coupling the surfaces 774 in the member 700 with the surfaces 674 in the feed tube rail 666. Consequently, the The feed boom 600 is held in position by the member 700 in accordance with the endoscope, the housing assembly and the carrier 500 are removed from the body. Figure 21 illustrates the feeding tube in place in the Gl tract of the patient after removal of the endoscope, the casing assembly and the holder 500. In Figure 21, the delivery tube 600 extends from the proximal end of the tube. 602 (placed outside the patient's body) to the distal end of the feeding tube 604 (placed in the small intestine), with the feeding tube 600 extending through the mouth, esophagus, stomach and into the small intestine. If desired, the feeding tube may be used in the position shown in Figure 21. However, it may generally be desirable to have the proximal end of the feeding tube extending from the nose. Figure 22 illustrates the use of a transfer tube 12 that can be inserted to extend from the mouth and nose. The end of the transfer tube extending from the mouth can be coupled to the proximal end 602 of the feeding tube, as shown in Figure 23. The end of the transfer tube 12 extending from the nose can then be pulled out of the nose. the way that the proximal end 602 of the feeding tube is redirected to extend from the nose, as shown in Figure 24. Next, a suitable fitting 14 can be attached to the proximal end 602 of the feed tube, as shown in Figure 24. Figures 25-30 illustrate an alternate method for placing a feeding tube. within a patient, to provide access of the feeding through an incision in the abdominal wall of the patient. Figures 25-30 illustrate a method for placing a feeding tube in the stomach as an alternative to standard PEG procedures. Referring first to Figure 25, the endoscope placed within the casing assembly comprising the handle 100, the casing 200 and the cap 400 can be advanced through the mouth to place the distal end of the endoscope and the cap 400 inside. of the patient's stomach. A light source (such as a light source associated with the distal end of the endoscope) can be used from within the stomach to transilluminate the abdominal wall, so that the position of the endoscope within the stomach can be seen from outside the patient. A small percutaneous incision can be made through the abdominal wall, and a needle 22 / cannula 24, such as a needle 22 / cannula 24 caliber 14 can be inserted through the incision, so that the distal tip of the needle and the The distal end of the cannula can be placed inside the stomach. Referring to Figure 26, the needle 22 can be withdrawn, leaving the cannula 24 to provide an access channel extending from the inside of the stomach to a point outside the patient. A loop guide wire 32 can be passed through the cannula, and the endoscope and housing assembly can be directed to extend through the loop provided by the guide wire 32. Referring to Figure 27, a tube is illustrated feeding 800 relatively short, the feeding tube has a length substantially less than the length of the slide 300. The feeding tube 800 in this embodiment can have a length of less than about 91.44 centimeters (3 feet). The feeding tube 800 may be a commercially available PEG type feeding tube, modified to have a characteristic, such as a rail (not shown), to allow the feeding tube 800 to be slidably engaged with the sliding guide 300 and / or the carrier 500. For example, the feeding tube 800 can be formed by attaching a mesh and a rail to a commercially available PEG feed tube, such as by attaching or otherwise adhering the mesh and rail to the tube. feeding (alternatively, the feeding tube 800 can be formed by extruding or otherwise forming a feeding tube so that it has an integral mesh and rail feature). A suitable commercially available PEG type feeding tube, from which the feeding tube 800 can be constructed, is available from Viasys Healthcare of Wheeling, IL, marketed in a PEG brand equipment Corflo-Max with a Push Technique or a Drag Technique. The feed tube 800 may include a stop or sealing support 810 and a tapered tip that expands 820. Referring to Figure 27, with the shell assembly extending through the loop provided by the guide wire 32, the feeding tube 800 can be advanced distally along the assembly of the casing and into the stomach. The feeding tube 800 can be placed on the slide 300 and advanced distally along the slide 300 towards the stomach, using the member 700 as a pusher. Alternatively, the feeding tube can be placed in the carrier 500, and the carrier 500 with the feeding tube 800 can be advanced along the slide guide 300 towards the stomach. Referring to Figure 28, the feeding tube 800 can be pushed out of the distal end of the wrapping assembly using a member, such as a member 700 described above. As the feeding tube 800 is pushed out of the wrap assembly, a suture 830 (or other suitable flexible wire or string), extending from the tip 820, can be secured with the guide wire 32, so that the suture 830 can be pulled through cannula 24.
Referring to Figure 29, the suture 830 can be pulled (such as with tweezers or a hemostat), so that the tip 820 extends through the percutaneous incision through the abdominal wall and so that the sealing stop 810 It is placed against the inner surface of the gastric wall (inside the surface of the stomach). Referring to Figure 30, the wrap assembly can be removed from the patient, and an outer seal 840 can be advanced over the feeding tube 800 to fit against the skin of the patient adjacent to the incision. The feeding tube 800 can be cut to separate the tip 820 from the feeding tube, and an accessory 850 can be placed at the end of the external feeding tube to the patient. In the procedure illustrated in Figures 25-30, a feeding tube is inserted into the patient through a natural hole and pushed distally along the endoscope after the endoscope has been placed in the stomach. The feeding tube is then pulled through an incision to provide an access channel for the feed that extends through an incision in the patient's Gl tract. Figures 31-37 illustrate the steps that can be employed in a method for positioning a feeding tube according to another embodiment of the present invention. Figures 25-30 illustrate a method for placing a feeding tube in the small intestine as an alternative for standard JET-PEG type procedures.
Referring first to Figure 31, the endoscope 1000 placed within the housing assembly comprising the handle 100, the housing 200 and the cap 400 can be advanced through the mouth to place the distal end of the endoscope and the cap 400 inside the patient's stomach. A light source (such as a light source associated with the distal end of the endoscope) can be used from within the stomach to transilluminate the abdominal wall, so that the position of the endoscope within the stomach can be seen from outside the patient. A small percutaneous incision can be made through the abdominal wall, and a needle 22 / cannula 24, such as a needle 22 / cannula 24 caliber 14, can be inserted through the incision, so that the distal tip of the needle and the distal end of the cannula can be placed inside the stomach. Referring to Figure 32, the needle 22 can be removed, leaving the cannula 24 to provide an access channel extending from the interior of the stomach to a point outside the patient. A loop guide wire 32 can be passed through the cannula, and the endoscope and the housing assembly can be directed to extend through the loop provided by the guide wire 32. The endoscope and the housing assembly can be made advancing distally from the stomach into the small intestine, as shown in Figure 32. Referring to Figure 33, a feeding tube 900 can be advanced along the assembly of the envelope so that the feeding tube 900 passes to through the loop provided by the guide wire 32. The feeding tube 900 shown in Figure 3 may include a distal portion 904 having a construction similar to that of the feeding tube 600 described above, and a proximal portion 906 having a construction similar to that of the feeding tube 800 described above. The proximal portion 906 may include a dilating tapered tip 920 and a stop or support 910. The proximal portion 906 may be constructed using a PEG feeding tube of the type provided in the Corflo-Max PEG Equipment for the Push Technique. or the Drag Technique, equipment which are available from Viasys Healthcare of Wheeling, IL. The opening through which the food is delivered to the Gl tract may be located in the distal portion 904. The feeding tube 900 may include a feature, such as a rail (such as the type shown in Figures 10, 11 and 13), in one or both of the portions 904 and 906, so that the feeding tube can slidably engage the slide guide 300 and / or the carrier 500. In one embodiment, the feeding tube 900 is placed in the carrier 500 outside the patient's body, and the feeding tube 900 and the carrier are advanced together along the slide 300. The positioning member 700 can be advanced along the carrier 500 behind the tube. feed 900. If desired, positioning member 700 may include a holding clamp 715 that can be secured or otherwise secured to member 700 to assist in holding and pushing member 700 along carrier 500. Referring As shown in Figure 34, with the positioning member 700 held in place, the endoscope and the housing assembly can be retracted proximally from the stomach, so that the feeding tube 900 is pushed out of the end of the housing assembly by the positioning member 700 as the endoscope and the housing assembly are retracted. A stretch of suture 930 extending from tip 920 can be secured using loop guide wire 32. Referring to Figure 35, suture 930 and tip 920 can be pulled through the incision until stop 910 it is placed with the inner surface of the stomach, with the portion 904 of the feeding tube that includes the opening through which the food is provided, being placed in the small intestine (such as the jejunum). Referring to Figure 36, an outer seal 940 can be advanced over the feeding tube 900 to fit against the skin of the patients adjacent to the incision. The feeding tube 900 can be cut to separate the tip 920 from the feeding tube, along with any unnecessary length of the tube, and an accessory 950 can be placed at the end of the external feeding tube to the patient. In Figure 37, the endoscope and the housing assembly are shown removed from the patient's body and the feeding tube 900 is shown positioned with the distal portion 904 placed in the small intestine, and with the feeding tube 900 extending from the small intestine through the stomach, to pass through an incision through the stomach and through the patient's wall and abdominal wall. In the procedure illustrated in Figures 31-37, a feeding tube is inserted into the patient through a natural hole and pushed distally together with an endoscope after the endoscope has been placed in the stomach. The feeding tube is then pulled through an incision to provide the feeding access channel that extends through a percutaneous incision in the patient's Gl tract (eg, the small intestine). Figures 38-42 illustrate a method to place a capacete 400 (such as an elastomeric cap 400) and an envelope 200 in an endoscope 1000, prior to inserting the endoscope into the housing assembly in the patient. In some applications, it may be difficult to manually load an endoscope into a casing having a cap, such as holding the components by hand. For example, it may be difficult to hold the endoscope through the wrapper and apply the appropriate force to urge the cap to fit over the distal end of the endoscope. In addition, it may be desirable to maintain a certain angular "in point" orientation of the cap with respect to the endoscope. By applying force to drive the cap on the endoscope, the desired point orientation can be lost inadvertently, requiring reinstallation. The method and components illustrated in Figures 38-42 can be employed to assist in the proper installation of a cap (and associated sheath and slide) in an endoscope. In addition, the method and components can be used to install a cap on an endoscope, even if a wrap and / or a slide is not used. Referring to Figure 38, a cap loading element is shown in the form of a cone with tip 2100. The tip cone 2100 may be disposable, and may be formed of a lightweight material, such as a polymeric material. The tip cone 2100 may include a body portion 2110 and a plurality of flexible pins 2120 (six pins are shown in Figure 38). The distal end 2102 of the body portion 2110 can be rounded or tapered. The body portion 2110 may include a through hole 2112 extending through the width of the body portion 2110, in a direction transverse to the longitudinal axis of the body portion 2110. The body portion 2110 and the pins 2120 may be sized and formed to pass through the opening of the central bore 420 of the cap 400. The portion of the body 2110 may include a plurality of radial grooves 2114 that extend along the portion of the body 2110. Each groove 2114 may be associated with a flange of the rounded or inclined tang 2118. Each flange of the tang 2118 may be associated with a flexible tang 2120. Each flexible tang 2120 may extend proximally from a flange of the tang 2118 to one end of the proximal tang 2122. Each flange of the rounded tang 2118 may extend radially outwardly from its associated groove 2114 in the body portion 2110 towards the tang flexible 2120 associated with that spigot flange. The radially outward surfaces of the grooves 2114 can define a first cone diameter with tip 2100, and the surface radially outwardly of the pegs 2120, can define a second cone diameter with tip, with the second diameter being larger than the first diameter. The radially outer surface of each flange of the rounded shank 2118 can be formed to provide a smooth radial transition from each groove towards its associated spike. Accordingly, the flanges of the rounded pegs 2118, together, provide a smooth radial transition from the first diameter to the second diameter. The radially inwardly facing surfaces of the flexible pins 2120 may be separated (either by being formed in that manner or due to an applied force) to receive the distal end of the endoscope 1000. The grooves 2114, the ridges of the rounded pins 2118 , and the pegs 2120 may be circumferentially spaced at generally equal angular intervals (eg, for six grooves, six flanges of the pegs, and six pegs, each groove, flange of the peg, associated flexible peg, could be separated at intervals of 60. degrees around the circumference of the body portion 2110).
Each peg 2120 may have a groove 2124 formed in the outward facing surface, as shown in Figure 38A and Figure 40A. Together, the slots 2124 in the pegs 2120 provide a circumferentially interrupted slit into which an expandable ring, such as a silicone O-ring or a Teflon O-ring 2160, can settle. The radial thickness 2123 of the pegs 2120 illustrated in FIG. Figure 38A, can be dimensioned to take into account various factors, such as the inner diameter and the material of the cap, the outer diameter of the distal end of the endoscope 1000, and the number of pins 2120 in the tip cone 2100, so that when the pins 2120 are placed between the outer surface of the distal end of the endoscope, and the inner surface of the cap, the radially inner surface of the cap is separated from the external surface of the endoscope. A suitable thickness 2123, where six pins 2120 are employed, is approximately 0.8128 millimeters (0.032 inches). Before seating the O-ring 2160 in the slots 2124, the distal end of the endoscope 1000 can be inserted between the pins 2120. The O-ring 2160 can then slide over the body 2110 of the tip cone 2100 and over the ridges of the rounded pins 2118 The O-ring can be stretched over the flanges 2118 and can be seated in the slots 2124 in the pins 2120. The O-ring can therefore provide a radially inward compression force on the pins 2120, driving the radially inwardly oriented surfaces. of the pins 2120 in engagement with the outer surface of the distal end of the endoscope 1000. With the tipped cone 2100 positioned at the distal end of the endoscope 1000, the endoscope 1000 is loaded into the housing assembly (comprising the handle 100, the envelope 200, the slide guide 300 and the cap 400). The endoscope is loaded in the housing assembly, so that the body portion 2110 of the tip cone 2100 extends distally from the shell 400, as shown in Figure 39, and so that the proximal face of the shell 400 joins butt against the flanges of the spikes. The O-ring 2160 and two proximal ends of the pin 2122 are shown in dashed lines in Figure 39, since the O-ring and the ends of the pin would be inside the casing (but may be visible when the casing 200 is made of a substantially transparent film material). Referring now to Figure 40 and Figure 40A, a handle 2200 is shown with a pair of outwardly extending arms 2204 extending from a central head 2208. The head 2208 includes a through-hole with slits 2210. The through hole 2210 has recesses dimensioned and formed to allow the handle 2200 to slide longitudinally along the grooves 2114 of the body portion 2110 in the tip cone 2100. The engagement of the grooves 2 14 with the grooved bore 2210, prevents the rotation of the handle 2200 with respect to the cone with tip 2100 and the shell 400. Although the rotation of the handle 2200 with respect to the tip cone 2100 could be allowed in an alternate mode that does not employ grooves and slits, it may be advantageous to avoid rotation of the handle 2200 with respect to the cone with tip 2100. For example, it may be desirable to load the cap 400 and the guide sliding 300 in the endoscope, in such a manner as to maintain a desired point orientation of the slide 300 with respect to features such as optical instruments and / or working channels at the distal end of the endoscope. Keeping the handle 2200 rotationally fixed with respect to the tip cone 2100, can help to avoid the angular misalignment of the slide guide 300 with respect to the distal end of the endoscope 1000. FIG. 40A illustrates the tip cone 2100 extending in the perforation 2210 from the proximal side of the handle 2200. The proximal side of the handle 2200 may include one or more surfaces to provide a pressing force against the distal surface 412 of the cap 400. In Figure 40A, the handle 2200 is shown as having multiple extensions with a generally wedge-shaped 2700 extending proximally from the grip 2200. In Figure 40A, six extensions 2700 are provided, one for each slit in the through-hole 2210. The extensions 2700 they can be separated by a distance substantially equal to the width of the slits in the through hole 2210. The extensions 2700 each have a proximally oriented surface 2710. Together, the surfaces 2710 can be coupled to the distal surface 412 of the pot 400, according to the handle 2200 is advanced proximally along the tip cone 2100. The proportion of spaced apart surfaces, 2710, may be beneficial to prevent the material of the cap 400 from being crushed between the tip cone 2100 and the grip 2200, as the handle 2200 provides a pushing force against the cap 400 and the pins 2120 provide a force of traction at the distal end of the endoscope. Referring to Figure 41, a closure ring 2300 is shown attached to a distal end of the tip cone 2100, such as with a bolt 2308 extending through the collar the closure ring 2304 and toward the through hole 2112 in the nose. cone with tip 2100. Combining the closure ring 2300 mounted on the distal end of the cone with tip 2100 and the handle 2200 slidably supported on the cone with tip 2100 via the groove and slit arrangement, allows the user to provide a force of traction (traction) on the endoscope 1000 through the cap 400, via the cone with tip 2100, while at the same time exerting a pushing force (compression), proximal on the distal face of the cap 400, via the surfaces 2710 of handle 2200. Referring to Figure 42, the application of such forces is illustrated schematically by arrows 2250 and 2350. When pulling closure ring 2300 in the direction indicated by to arrow 2350, while the handle 2200 is pushed in the direction indicated by the arrows 2250, the cap 400 is pushed towards the distal end of the endoscope 1000 and the O-ring is pushed out of the pins 2120, so that the pins 2120 they can be uncoupled from the distal end of the endoscope 1000 and can be pulled through the through hole 420 of the cap 400. The O-ring 2160 can remain positioned around the proximal endoscope of the cap 400. In the installation mode shown in Figures 38-42, a distal pulling force is applied to the outer surface of the endoscope 1000 with flexible pins 2120, as a proximal pushing force is provided by the handle 2200 against the distal face of the cap 400. Figures 43-47 illustrate an alternate apparatus and method to be used to place a cap on an endoscope, which can be used to provide a drag force on an internal surface of an endoscope, such as an inner surface of a working channel of an endoscope, as a pushing force is applied to the cap. The wrap and the slide guide are omitted from the Figures for clarity, it being understood that the apparatus and method illustrated in Figures 43-47 can be used to place a shell on the distal end of an endoscope, including in applications where it is not employed. a wrapping and / or sliding guide. Figure 43 is a schematic isometric view of the loading apparatus 3000, and Figure 44 is a partial cross-sectional illustration of the apparatus 3000. In Figures 43 and 44, the shell 400 is shown for illustration purposes, it being understood that the shell 400 is not part of the apparatus 3000. Figures 45, 46 and 47 illustrate the steps in which the apparatus 3000 is used to load a cap 400 on an endoscope, with the endoscope and the cap being illustrated as generally transparent for purposes of illustration and clarity (although the capacete 400 and the endoscope could be formed of generally transparent materials, if desired). The apparatus 3000 includes a body section 3100, a turning section 3200 and a translation section 3300, and a ring 3400. As shown in Figures 45 and 46, the apparatus 3000 may include one or more expandable members, such as elastic cylinders 3500, which can couple an internal surface of the endoscope, such as when placed inside a working channel of the endoscope. The cylinders 3500 may be formed of any suitable material, such as rubber or synthetic elastomeric materials, which expand radially when compressed axially. Alternatively, other types of expandable members, such as members that expand by inflation, may be employed. Referring to Figure 46, the cylinders 3500 can be expanded to engage the inner surface of the working channel. The expansion of the rubber cylinders can be provided in part, relative to the rotation of the turning section 3200, as described more fully below.
Referring to Figure 47, with the cylinders 3500 expanded within the working channel of the endoscope for compressively engaging the radially internal surface of the working channel, the translation section 3300 can be withdrawn distally relative to the body section 3100 (as indicated by arrows 3302 in Figure 47). As shown in the Figures, the body section 3100 can include a recess 3120 having a proximally oriented surface 3122 for engaging the distal surface 412 of the cap 400. As the translational section 3300 is withdrawn distally relative to the body section 3100, the cylinders 3500 can be retracted distally relative to the body section 3100. Accordingly, the combination of the drag force provided in the endoscope by the cylinders 3500 which are pulled distally while coupling the inner surface of the working channel, and the complementary reactive pushing force exerted on the distal surface 412 of the cap 400 by the surface 3122 serves to press the cap 400 on the distal end of the endoscope. Accordingly, the apparatus 3000 can be used to install the cap 400 on the distal end of the endoscope without holding or otherwise contacting the outer surface of the endoscope or the enclosure (if a wrap is used). The components and operation of the apparatus 3000 will now be described in more detail with reference to Figures 43-47, as well as the cross sectional illustrations 48 and 49. The body portion 3100 may include an outer surface provided by two body halves 3106 and 3108. The body halves can be joined in any suitable manner, such as with fasteners of the screw type, rivets, with adhesive and the like. The translation section 3300 may be located at least partially within the body portion 3100, and may include a head 3316 and outwardly extending annular retainers 3318. The annular retainers 3318 may extend outwardly from the head 3316 through the slots provided between the cover halves of the body portion 3106 and 3108. Referring to Figure 44 and Figure 48, the turning section 3200 can be supported at one end of the body portion 3100, such that the turning section 3200 rotates with respect to the body portion 3100, and so that the turning section rotates with respect to the translation section 3100. As shown in Figure 48, the turning section 3200 may have an end 3202 received within a recess 3105, provided by the body halves 3106 and 3108. The end 3202 may include a ring 3204 formed on an outer surface of the end. 3202. The ring 3204 is received in a slit 3107, which can be formed on the internal surfaces of the body halves 3106 and 3108. The correspondence of the ring 3204 in the slit 3107 allows the section 3200 to rotate with respect to the section of the body. body 3100, while preventing translation of section 3200 with respect to body section 3100.
The turning section 3200 can include a collar 3208 that can be held by the fingers to rotate the section 3200. The ring 3400 can be supported at one end of the turning section 3200, so that the ring 3400 can rotate freely about the longitudinal axis of the turning section 3200, independently of the position of the turning section 3200. Accordingly, the ring 3400 can be aligned to have the same flat orientation as the ring retainers 3318 on the translation section 3300, regardless of how it rotates the turning section 3200. Figure 48 provides an enlarged schematic cross-sectional illustration of the portions of the translation section 3300 and the turning section 3200, and Figure 49 provides an enlarged schematic cross-sectional illustration of the portions of the apparatus. which are used to attach the cap or the endoscope. The translation section 3300 may have a central bore 3342 extending along the translation section. The central perforation 3342 is shown as including an elongated perforation section 3344, which extends along the head 3316. A shaft 3350 extends through a central through hole 3342, and is dimensioned with respect to the hole 3342 and supported in the hole 3342 to rotate freely within the hole 3342. The shaft 3350 can extend from a first end 3352, to a second end 3354. The second end 3354 can have an elongated diameter relative to the remaining length of the shaft 3350, so that the second end 3354 can be used to compress the 3350 cylinders Referring to Figure 48, an internally threaded member 3360 is positioned at one end of the head 3316. The internally threaded member 3360 may be in the form of a nut having an internally threaded through hole, which is generally aligned in a manner that coaxial with respect to the central bore 3342 and the section of the elongated bore 3344. The internally threaded member 3360 is fixed with respect to the translation section 3300. The rotation section 3200 may include a longitudinally extending internal channel 3242, which is generally aligned coaxially with respect to the bore 3342. An externally threaded member 3260 is positioned to slide in the bore 3242. The member 3260 may be in the form of a screw having a non-circular head 3262, a longitudinally extending external threaded portion 3264, and a longitudinally extending through-hole 3266. The through-hole 3266 extends along the screw 3260, and may have an internal diameter sized to receive the 3350 axle through. The through hole 3266 can be dimensioned so that the shaft 3350 can rotate freely with respect to the screw 3260. The head 3262 of the screw 3260 can be in the form of a regular polygon. The perforation 3242 in the turning section 3200 can have a non-circular cross-sectional shape, similar to that of the head 3262 (for example, a hexagonal cross-section if the head 3262 is hexagonal), so that the screw 3260 can moved in the perforation 3242 relative to the turning section 3200, but in such a way that the screw 3260 is prevented from rotating with the turning section 3200. Alternatively, the screw 3260 may have a head 3262, which includes a key or another feature to allow sliding translation of the screw 3260 within the bore 3242, while ensuring that the screw rotates with the turning section 3200. A shaft collar 3356 is positioned at or near the end of the axis 3352 of the shaft 3350. Shaft collar 3356 can be fixed to shaft 3350, such as with a fixed screw, bolt, adhesive or any other suitable fastening means to secure collar 3356 on shaft 3350. Collet Ain 3356 may be placed in bore 3242, and has an outer diameter sized to allow collar 3356 to move and rotate freely with respect to turning section 3200. A surface 3358 of collar 3356 may be butted or otherwise engaged. an end surface of the screw head 3262, as shown in Figure 48. Referring to Figure 49, the cylinders 3500 can be supported on a portion of the shaft 3350, which extends from the bore 3342. The cylinders 3500 can be supported on a portion of the shaft 3350 extending outward from an end face 3302 of the translation section 3300. A cylinder 3500 can be positioned on the shaft 3350 between the end of the shaft 3354 and a spacer 3352. The spacer 3352 is formed of a material that is relatively harder and less elastic than the cylinders 3500, and the spacer 3352 may be in the form of a metal washer. Second cylinder 3500 can be placed on shaft 3350 between spacer 3352 and a pair of spacers 3354. Spacers 3354 can be placed on shaft 3350 between second cylinder 3500 and end face 3302, as shown in Figure 49. To employ the apparatus 3000 for loading a cap on an endoscope, the apparatus 3000 is positioned with respect to the cap and the endoscope as shown in Figure 45, with the translation section 3300 in a front position with respect to the body section 3100, with the end of the shaft 3350 and the cylinders 3500 placed in the working channel of the endoscope; with the end face 3302 of the translation section 3300 against the distal end face of the endoscope, and with the surface 3122 of the body section 3100 against the distal face of the cap. The turning section 3200 is then rotated (such as via collar 3208), which rotation causes the screw 3260 to rotate inside the nut 3360. As the screw 3260 rotates, the screw 3260 moves in a rearward direction in perforation 3242, in accordance with the pitch of the thread in the screw 3260. The backward movement of the screw 3260 pushes the shaft collar 3356 rearward, which, in turn, causes the shaft 3350 and the shaft end 3354 move backward relative to the translation section 3100, thereby compressing the cylinders 3500 and causing the cylinders to radially expand and compressively engage the inner surface of the working channel of the endoscope. Next, with the 3500 cylinders expanded in the working channel of the endoscope, the thumb can be inserted into the ring 3400 and two fingers can be inserted into the ring retainers 3318. The fingers on the ring retainers 3318 can exert a force back on the translation section 3300, so that section 3300 is drawn backward with respect to body section 3100. Removal of translation section 3300 backward as shown in Figure 47 (in the direction of arrows 3302) , it also results in the 3350 axle and the 3500 cylinders moving backwards. Because the shaft 3350 and the cylinders 3500 move back together with the translation section 3300, the cylinders do not expand further. The backward force on the 3350 axis (tensile force on the 3350 axis) and the 3500 cylinders (which attach the inner surface of the endoscope), exerts a force backward on the endoscope (drag force on the endoscope), while the surface 3122 in the body section 3100, pushes the distal face of the cap. Accordingly, as the section 3300 is pulled back with respect to the body section 3100, a pulling force is exerted on an inner surface of the endoscope, while a pushing force is exerted on a distal face of the cap, urging thus the cap towards the distal end of the endoscope.
Although the present invention has been illustrated by the description of various embodiments, it is not the intention of the applicant to restrict or limit the spirit and scope of the claims appended to such details. Numerous other variations, changes and substitutions will occur to those skilled in the art, without departing from the scope of the invention. For example, the device and method of the present invention has been illustrated in relation to the deployment of a feeding tube through the mouth and esophagus, but it will be understood that the present invention has applicability to other portions of the body, and For example, it could be used to direct medical accessories to the body through other openings, including other natural openings in the body. In addition, the structure of each element associated with the present invention can be described alternately as a means to provide the function performed by the element. It will be understood that the foregoing description is provided by way of example, and that other modifications may occur to those skilled in the art, without departing from the scope and spirit of the appended claims.

Claims (14)

NOVELTY OF THE INVENTION CLAIMS
1. - An apparatus for placing a device at one end of an endoscope, the apparatus comprising: a first component for applying a force to the device; and a second component operatively associated with the first component and movable with respect to the first component, wherein the second component is adapted to apply a force to the endoscope through an opening in the device.
2. The apparatus according to claim 1, further characterized in that the first component is adapted to apply a force to the device, simultaneously with the second component that applies a force to the endoscope.
3. The apparatus according to claim 1, further characterized in that the second component is adapted to apply a force to an external surface of the endoscope.
4. The apparatus according to claim 1, further characterized in that the second component is adapted to apply a force to a surface associated with an internal passage in the endoscope.
5. - The apparatus according to claim 1, further characterized in that it comprises a component that is expandable to couple the endoscope.
6. The apparatus according to claim 1, further characterized in that the first component is adapted to apply a pushing force to the device, and wherein the second component is operatively associated with the first component, to apply a force of traction to the endoscope, simultaneously with the application of the pushing force.
7. An apparatus for placing a cap on the distal end of an endoscope, the apparatus comprises: a loading element comprising a first end and a second end, the first end is sized to pass through the cap, and the second end is adapted to releasably couple the distal end of the endoscope.
8. The apparatus according to claim 7, further characterized in that the loading element comprises a plurality of elastic pins.
9. The apparatus according to claim 8, further characterized in that it comprises a ring sized to pass over the first end of the loading element and capable of expanding on the pins.
10. The apparatus according to claim 8, further characterized in that it comprises a member slidable with respect to the loading element and having a surface to apply a force to the cap.
11. An apparatus for use in association with an endoscope, the apparatus comprises: a component having a first configuration that is received in a passage in an endoscope, and a second configuration for coupling an internal surface of the passageway; and a mechanism operably associated with the member to reversibly change the member between the first configuration and the second configuration.
12. The apparatus according to claim 11, further characterized in that the component is expandable from a first diameter associated with the first configuration to have a second larger diameter associated with the second configuration.
13. The apparatus according to claim 11, further characterized in that it comprises a translation section and a turning section, wherein the turning section is operable to reversibly change the component between the first and second configurations, and in where the translation section is operable to provide a pulling force on the component.
14. The apparatus according to claim 11, further characterized in that the mechanism is operable to compress the component in a first direction, and wherein the compression of the component in the first direction causes the component to expand in a second direction, to attach the internal surface of the passage in the endoscope.
MXPA/A/2006/005502A 2005-05-13 2006-05-15 Apparatus useful for positioning a device on an endoscope MXPA06005502A (en)

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US11128704 2005-05-13

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MXPA06005502A true MXPA06005502A (en) 2008-09-02

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